GUDAIR

Main information

  • Trade name:
  • GUDAIR
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GUDAIR
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Mycobacterium
  • Therapeutic area:
  • Goats Food, Sheep Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • ES/V/0210/001
  • Authorization date:
  • 27-06-2013
  • EU code:
  • ES/V/0210/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

GUDAIR

Emulsionforinjectionforsheepandgoats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachdose(1ml)ofthevaccinecontains:

Activesubstance:

Mycobacteriumparatuberculosisinactivated,strain316F ≥2mmITTavianPPD*

*Increaseoftheskinthicknessintheintradermaltuberculintestinsheepwithavian

proteinderivativeandincomparisonwithbovineproteinderivative.

Adjuvant(s):

Mineraloil(Marcol52) 0.38mL

Montanide103 0.021mL

Montane80 0.021mL

Excipients:

Thiomersal 0.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Emulsionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Sheepandgoats

4.2 Indicationsforuse,specifyingthetargetspecies

Activeimmunisationofsheepandgoatstoreduceclinicalsigns,lesionsandmortality

causedbyM.paratuberculosis.ItalsoreducesM.paratuberculosisfaecalsheddingin

sheep.

4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

VaccinationsensitisesanimalsagainstjohninPPD(PurifiedProteinDerivativeof

Mycobacteriumaviumsubsp.paratuberculosis),aviantuberculinPPD(derivativeof

Mycobacteriumavium)andtolesserextendbovinetuberculinPPD(derivativeof

Mycobacteriumbovis).ThereactionagainstaviantuberculinPPDismoreintensethan

againstbovinetuberculinPPDandclearlydistinguishable.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useuninterruptedlyoncetheextractionofthecontentisinitiated.

Shakewellbeforeuse.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Totheuser:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresultinsevere

painandswelling,particularlyifinjectedintoajointorfinger,andinrarecasescould

resultinthelossoftheaffectedfingerifpromptmedicalattentionisnotgiven.

Ifyouareaccidentallyinjectedwiththisproduct,seekpromptmedicaladviceevenif

onlyaverysmallamountisinjectedandtakethepackageleafletwithyou.

Ifpainpersistsformorethan12hoursaftermedicalexamination,seekmedicaladvice

again.

Tothephysician:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,accidental

injectionwiththisproductcancauseintenseswelling,whichmay,forexample,resultin

ischaemicnecrosisandeventhelossofadigit.Expert,PROMPT,surgicalattentionis

requiredandmaynecessitateearlyincisionandirrigationoftheinjectedarea,

especiallywherethereisinvolvementoffingerpulportendon.

4.6Adversereactions(frequencyandseriousness)

Inrarecases,hypersensitivityreactionsmayoccur.Inthiscase,administerasuitable

antihistaminetherapywithoutdelay.

Thevaccineproducesswellingattheinjectionsitewhichgraduallybecomesa

persistent,fibrousandcoldnodule.Thiseventisverycommon.

Nodulecanbedetectedat1-2weekspostvaccinationwithmediumsizeof

approximately2cminsheepandgoats,reachingameanmaximumsizeof3.5cmin

sheepand4cmingoatsat2monthspostvaccination,decreasinguntil1yearafter

vaccination.

Rarely,thediametercanreachvaluesgreaterthan5cmat2monthsaftervaccination.

Palpablelesionscanbeobservedinthe20-25%ofthesheepat4yearspost

vaccination.

Nodulesdisappearnormallywithouttreatment.

Inthosecaseswherethevaccineisinoculatedtoinfectedanimals(secondary

antigenicimpact),itcanbeobservedamoreintenselocalreaction.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheveterinaryproducthasnotbeenestablishedduringpregnancyor

lactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwith

anyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafter

anyotherveterinarymedicinalproductthereforeneedstobemadeonacasebycase

basis.

4.9 Amountstobeadministeredandadministrationroute

Dosage:1mL

Subcutaneousroute.

Vaccinationschedule

Administeronedoseofvaccinetoallreplacementanimalsbetween2-3weeksandsix

monthsofage,sothatitisrecommendedtovaccinatethemassoonasposible.In

affectedoratriskflocksandherdsorgroupsofanimals,thevaccinationshouldbe

carriedoutonallindividuals,includingadultanimals.

Ingeneral,itisnotnecessarytorevaccinate.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Itdoesnotprovokeadversereactionsdifferentfromthoseproducedbythevaccination

withasingledoseorwithanoverdosewithadoubledoseandstatedinpoint4.6.

4.11Withdrawalperiod(s)

Zerodays

5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Inactivatedbacterialvaccinesagainstparatuberculosisin

sheepandgoats.

ATCvetcode:QI04AB09andQI03AB01

ForstimulatingtheactiveimmunityagainstMycobacteriumparatuberculosisinsheep

andgoats

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Marcoloil52

Montanide103

Montane80

Polysorbate80

Thiomersal

Phosphatebufferedsaline

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:immediateuse

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(between+2

Cand+8

C).Protectfromlight.Donot

freeze.

6.5Natureandcompositionofimmediatepackaging

TypeIIGlassbottles(accordingtotheEur.Ph.)of30mL(30doses)withrubber-nitrile

stopperandaluminiumseal.

Packagesize:

Cardboxwith1glassbottleof30ml(30doses).

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

CZVeterinaria,S.A.

LaRelvas/n-Torneiros

36400PORRIÑO(Pontevedra)

8. MARKETINGAUTHORISATIONNUMBER(S)

2792ESP

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:02/02/1994

Dateofrenewal:25/04/2013

10 DATEOFREVISIONOFTHETEXT

April2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Conditionsofdispensing:Medicinesubjecttoveterinaryprescription

Conditionsofadministration:Administrationundercontrolorsupervisionofa

veterinarysurgeon.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cardboxof1glassbottleof30mL

CN

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

GUDAIR

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachdose(1ml)ofthevaccinecontains:

Activesubstance:

Mycobacteriumparatuberculosisinactivated,strain316F ≥2mmITTavianPPD*

*Increaseoftheskinthicknessintheintradermaltuberculintestinsheepwithavian

proteinderivativeandincomparisonwithbovineproteinderivative.

Adjuvant(s):

Mineraloil(Marcol52) 0.38mL

Montanide103 0.021mL

Montane80 0.021mL

Excipients:

Thiomersal 0.1mg

3. PHARMACEUTICALFORM

Emulsionforinjection

4. PACKAGESIZE

30mL(30doses)

5. TARGETSPECIES

Sheepandgoats

6. INDICATION(S)

Activeimmunisationofsheepandgoatstoreduceclinicalsigns,lesionsandmortality

causedbyM.paratuberculosis.ItalsoreducesM.paratuberculosisfaecalsheddingin

sheep.

7. METHODANDROUTE(S)OFADMINISTRATION

Shakewellbeforeuse.

Readthepackageleafletbeforeuse.

Subcutaneousroute.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous.

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

Month/Year

Onceopen,useimmediately.

11.SPECIALSTORAGECONDITIONS

Storeandtransportrefrigerated.Protectfromlight.Donotfreeze.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Eliminateanyresidueinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

VeterinaryUseOnly

Medicinesubjecttoveterinaryprescription

Administrationundercontrolorsupervisionofaveterinarysurgeon

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

CZVeterinaria,S.A.

P.O.Box16

PORRIÑO(Pontevedra)

16.MARKETINGAUTHORISATIONNUMBER(S)

Reg.No.:2792ESP

17. MANUFACTURER’SBATCHNUMBER

BatchNo.

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Bottleof30mL

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

GUDAIR

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Activesubstance:

Mycobacteriumparatuberculosisinactivated,strain316F ≥2mmITTavian

PPD*

*Increaseoftheskinthicknessintheintradermaltuberculintestinsheepwithavian

proteinderivativeandincomparisonwithbovineproteinderivative.

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

Dosage:1mL

30mL(30doses)

4. ROUTE(S)OFADMINISTRATION

Subcutaneousroute

5. WITHDRAWALPERIOD

Zerodays

6. BATCHNUMBER

BatchNo.:

7. EXPIRYDATE

Month/Year

Onceopened,useimmediately.

8. THEWORDS“VETERINARYUSE”

Veterinaryuse

PACKAGELEAFLET

GUDAIR

Emulsionforinjectionforsheepandgoats

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLE

FORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturerresponsibleofbatchrelease:

CZVeterinaria,S.A.

LaRelvas/n

36400Porriño(Pontevedra)

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

GUDAIR

Emulsionforinjectionforsheepandgoats

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachdose(1ml)ofthevaccinecontains:

Activesubstance:

Mycobacteriumparatuberculosisinactivated,strain316F ≥2mmITTavianPPD*

*Increaseoftheskinthicknessintheintradermaltuberculintestinsheepwithavian

proteinderivativeandincomparisonwithbovineproteinderivative.

Adjuvant(s):

Mineraloil(Marcol52) 0.38mL

Montanide103 0.021mL

Montane80 0.021mL

Excipients:

Thiomersal 0.1mg

4. INDICATION(S)

Activeimmunisationofsheepandgoatstoreduceclinicalsigns,lesionsandmortality

causedbyM.paratuberculosis.ItalsoreducesM.paratuberculosisfaecalsheddingin

sheep.

5. CONTRAINDICATIONS

None

6. ADVERSEREACTIONS

Inrarecases,hypersensitivityreactionsmayoccur.Inthiscase,administerasuitable

antihistaminetherapywithoutdelay.

Thevaccineproducesswellingattheinjectionsitewhichgraduallybecomesa

persistent,fibrousandcoldnodule.Thiseventisverycommon.

Nodulecanbedetectedat1-2weekspostvaccinationwithmediumsizeof

approximately2cminsheepandgoats,reachingameanmaximumsizeof3.5cmin

sheepand4cmingoatsat2monthspostvaccination,decreasinguntil1yearafter

vaccination.

Occasionally,thediametercanreachvaluesgreaterthan5cmat2monthsafter

vaccination.Palpablelesionscanbeobservedinthe20-25%ofthesheepat4years

postvaccination.

Nodulesdisappearnormallywithouttreatment.

Inthosecaseswherethevaccineisinoculatedtoinfectedanimals(secondary

antigenicimpact),itcanbeobservedamoreintenselocalreaction.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

.

7. TARGETSPECIES

Sheepandgoats

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Dosage:1mL

Subcutaneousroute.

Vaccinationschedule

Administeronedoseofvaccinetoallreplacementanimalsbetween2-3weeksandsix

monthsofage,sothatitisrecommendedtovaccinatethemassoonasposible.In

affectedoratriskflocksandherdsorgroupsofanimals,thevaccinationshouldbe

carriedoutonallindividuals,includingadultanimals.

Ingeneral,itisnotnecessarytorevaccinate.

9. ADVICEONCORRECTADMINISTRATION

Avoidadministrationintheareasofsupportandrubbing

10.WITHDRAWALPERIOD

Zerodays

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeandtransportinfridge(between+2ºCand+8ºC).Protectfromlight.Donot

freeze.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:immediateuse,

Donotusethismedicineaftertheshelf-lifeindicatedinthecardboxandlabelafter

CADorEXP.

12.SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

VaccinationsensitisesanimalsagainstjohninPPD(PurifiedProteinDerivativeof

Mycobacteriumaviumsubsp.paratuberculosis),aviantuberculinPPD(derivativeof

Mycobacteriumavium)andtolesserextendbovinetuberculinPPD(derivativeof

Mycobacteriumbovis).ThereactionagainstaviantuberculinPPDismoreintensethan

againstbovinetuberculinPPDandclearlydistinguishable.

Specialprecautionsforuseinanimals

Shakewellbeforeuseanduseuninterruptedlyoncetheextractionofthecontentis

initiated.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Totheuser:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresultinsevere

pain

andswelling,particularlyifinjectedintoajointorfinger,andinrarecasescouldresult

inthelossoftheaffectedfingerifpromptmedicalattentionisnotgiven.

Ifyouareaccidentallyinjectedwiththisproduct,seekpromptmedicaladviceevenif

onlyaverysmallamountisinjectedandtakethepackageleafletwithyou.

Ifpainpersistsformorethan12hoursaftermedicalexamination,seekmedicaladvice

again.

Tothephysician:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,accidental

injectionwiththisproductcancauseintenseswelling,whichmay,forexample,resultin

ischaemicnecrosisandeventhelossofadigit.Expert,PROMPT,surgicalattentionis

requiredandmaynecessitateearlyincisionandirrigationoftheinjectedarea,

especiallywherethereisinvolvementoffingerpulportendon.

Useduringpregnancy,lactationorlay:

Thesafetyoftheveterinaryproducthasnotbeenestablishedduringpregnancyor

lactation

Interactionswithothermedicamentsorotherinteractionforms:

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwith

anyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafter

anyotherveterinarymedicinalproductthereforeneedstobemadeonacasebycase

basis.

Overdose(symptoms,emergencyprocedures,antidotes):

Itcan’tbeobservedanydifferentadversereactionsproducedbyasingledoseor

becauseofanoverdose,thanthoseindicatedinpoint6.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarianorpharmacisthowtodisposeofmedicinesnolongerrequired.

Thesemeasuresaredesignedtoprotecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

April2013

15.OTHERINFORMATION

Formats:

Cardboxwith1glassbottleof30mL(30doses).

Conditionsofdispensing:Medicinesubjecttoveterinaryprescription

Conditionsofadministration:Administrationundercontrolorsupervisionofa

veterinarysurgeon.

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